The objective of this study is to assess the efficacy of Pentoxifylline in the treatment of autism. Fourty children between the ages 3 and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who will be outpatients from a specialty clinic for children will be recruited. The children should present with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients will be randomly allocated into Pentoxifylline (200- 400 mg/day) + Risperidone (3.5mg/day) or Placebo + Risperidone (3.5mg/day) for a 10-week, double-blind, placebo-controlled study. Patients will be assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711161556N7
Registration date:2009-03-13, 1387/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-03-13, 1387/12/23
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-04-20, 1386/01/31
Expected recruitment end date
2009-04-20, 1388/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double- blind placebo controlled trial of Pentoxifylline added to Risperidone in patients with autistic disorders
Public title
Pentoxifylline in the treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM IV clinical diagnosis of autism, children and adolescents between the ages of 3 and 11 years (inclusive),
Exclusion Criteria: Presence of any active medical problem, any diagnosis in Axis I and II except for mental retatdation, history of allergy to Pentoxifylline, receiving any psychotropic medications during past two weeks prior to the trial, presence of aggressive behavior that needs Risperidone